Quality Compliance Analyst — Regulatory Submissions

Cardinal Health; Boise (ID); Remote; USD 38,000 - 48,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Specialist, Quality Compliance to support the development and deployment of policies, procedures and programs designed to minimize risk and enable compliant business operations, products and services across the supply chain. This country-wide remote role will involve assisting on regulatory submissions and inspections under supervision.

The role supports field action activities, monitors adherence to procedures, and collaborates with senior team members on

Qualifications

• 0-2 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred

Responsibilities

• Supports field action activities by preparing, compiling, and coordinating required regulatory reports and submissions for internal review and approval.
• Supports implementation of quality and compliance programs by monitoring adherence to established procedures, policies, and applicable regulatory requirements, and providing guidance to internal stakeholders as needed.
• Collects, analyzes, and summarizes quality and compliance data to support regulatory inquiries, inspections, management review activities, and continuous improvement initiatives.
• Handles and ensures quality of documentation (control, retention, and archival) to support field action activities.
• Promotes and supports adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.
• Assist in the preparation for and execution of regulatory inspections and audits.
• Partners with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge and process of applicable regulations and internal quality requirements.

Education

Bachelor's degree in related field

Job description

Cardinal Health is seeking a Specialist, Quality Compliance to support the development and deployment of policies, procedures and programs designed to minimize risk and enable compliant business operations, products and services across the supply chain. This country-wide remote role will involve assisting on regulatory submissions and inspections under supervision.

The role supports field action activities, monitors adherence to procedures, and collaborates with senior team members on